COVID-19 and Multiple Sclerosis Disease Modifying Therapies

NCT04863586 | Unknown

• 1 other identifier: 20NS041
• Study Type: observational
• Target: 14,240
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 pandemic is a major concern for people on long-term treatments that modify the immune system function. People with multiple sclerosis (pwMS) form a large group who receive such treatments called disease modifying therapies (DMTs). Several types of DMTs with different effects on the immune system are being used for multiple sclerosis (MS). In the absence of large-scale national studies, the risk of COVID-19 among pwMS on various DMTs has not been established. A few physician-reported registry-based studies have suggested that anti-CD20 monoclonal antibodies, such as ocrelizumab and rituximab, used in the treatment of MS can increase the risk of COVID-19. However, in our community-based COVID-19 study of a large cohort of pwMS as part of the UK MS Register, we could not demonstrate an association between DMTs and susceptibility to COVID-19. Other studies have not found any relationship between DMTs and the outcome of COVID-19 among pwMS. To our knowledge, UK is the only country in the world that collects national data on DMT use, providing us with the opportunity to investigate the impact of DMTs on COVID-19 susceptibility and severity in a large population of pwMS. In England, no DMT is being dispensed without prior approval and specialised commissioning by the national Health Services (NHS) England \& NHS Improvement (NHSE/I). The scheme, currently implemented in over 100 NHS Trusts in England, ensures that treatment decisions are made in line with agreed commissioning policy and are evidence-based. NHSE/I also has access to Public Health England (PHE) held data on all people who have had a SARS-CoV-2 test. By identifying all pwMS on DMTs and all those who have had a test for coronavirus and collecting data on the clinical outcome of their COVID-19 from their local NHS hospitals, we would be able to establish the risk of COVID-19 and the risk of contracting the infection associated with different DMTs. The findings of the study will help MS clinical teams address the concerns of pwMS about taking DMTs during the COVID-19 pandemic and update their guidelines on the measures pwMS need to take during these unprecedented times.

Conditions

Covid19; Multiple Sclerosis

Keywords

Covid19; Multiple sclerosis; Disease modifying therapies

Outcome Measures

Primary Outcomes (1)

• Prevalence of testing positive for SARS-CoV-2 in people with MS taking DMTs

  The number of people with MS taking DMTs who have tested positive for SARS-CoV-2 among all people with MS taking DMTs in England.

  6 months

Secondary Outcomes (3)

• Clinical outcomes of COVID-19 among people with MS taking DMTs

  6 months

• Risk of contracting COVID-19 associated with individual DMTs/other clinical and paraclinical factors

  6 months

• Association between clinical outcomes of COVID-19 and individual DMTs/other clinical and paraclinical factors

  6 months

Study Arms (2)

Tested positive for SARS-CoV-2

Eligible participants who have had a positive SARS-CoV-2 test will be included in the case group of the study.

Not tested for SARS-CoV-2

A random sample of age, sex, and DMT matched people with MS who have not been tested for SARS-CoV-2 will be included in the control group of the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is all people with MS taking DMTs in England.

You may qualify if:

• Age 18 or above
• Diagnosed with MS
• Received treatment with a DMT

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nikos Evangelou, FRCP

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 28, 2021
• Study Start: April 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: May 31, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)